C

Validation Analyst

icon building Company : Clinchoice
icon briefcase Job Type : Full Time

Number of Applicants

 : 

000+

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Job Description - Validation Analyst


Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….


ClinChoice, is searching for a Validation Analyst to join one of our partner companies, a large pharmaceutical company leader in the field of biomedicines, where you will work office-based in Ghent, 1.0 FTE until December 2026.


As Validation Analyst you will be part of shaping the start-up of the CAR-T production process in Ghent. You will be part of tech transfer, validation plan, sterilization validation, equipment introduction and technical writing.


ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.  


 


Main Job Tasks and Responsibilities:



  • Define strategy, plan, and coordinate validation activities such as sterilization, hold time validation, APQ and APS.

  • Provides guidance on aspects of validations and qualifications.

  • Assure revalidation of manufacturing and sterilization processes.

  • Write, review and approval of sterilization, APS and other related validation plans, protocols and reports.

  • Participate in product transfer and system introduction teams.

  • Participate in system and process improvement / optimization projects.

  • Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology.


 


Education and Experience:



  • University/Bachelor’s Degree or higher in engineering, biotech, biomedical sciences or pharmacy.

  • Ability to manage complexity, strict deadlines and change.

  • Ability to interact at different levels of the organization.

  • Ability to work under pressure, handle conflicting interests, having a good sense of prioritization of assigned tasks goals and manage time accordingly.

  • Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.

  • Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations.

  • Strong working knowledge of current Good Manufacturing Practices (cGMP).

  • Experience working in a controlled, cleanroom environment under aseptic conditions is a plus, but not a must.

  • Project Management - provide timely and accurate reporting on project activities to peers and leadership.

  • Proficiency in written and oral English, with a desirable command of Dutch.


 


The Application Process


Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.


 


Who will you be working for?


 


About ClinChoice    


ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.       


 


Our Company Ethos


Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.


ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.


Key words: Validation Analyst, CAR-T, GMP, Validation plan, sterilization validation, APS, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated.


 


#LI-CM1 #TEMPORARY


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